United States
Company name: Bayshore Pharmaceuticals, LLS
Brand name: Bayshore Pharmaceuticals, LLS
Product recalled: Metformin Hydrochloride Extended-Release Tablets USP, 500 mg & 750 mg
Reason of the recall: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: August 20, 2020
Recall details: Company Announcement Bayshore Pharmaceuticals, LLC, Short Hills, NJ is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit. This product was manufactured by Beximco Pharmaceuticals Limited, Dhaka, Bangladesh in June 2019, for U.S. distribution by Bayshore. Bayshore was notified by the U.S. Food and Drug Administration (US FDA) that one lot (Lot number 18657) of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Bayshore has agreed to recall this lot, and out of an abundance of caution, the company has tested samples from eight (8) lots of Metformin Hydrochloride Extended-Release Tablets manufactured using same API lot of the failed lot. Out of eight (8) lots, one lot (Lot number 18657) of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg and one lot (Lot number 18641) of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg have showed N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). Hence, Bayshore has decided to recall the two lots (Lot number 18641 and 18657). To date, neither Bayshore nor Beximco have received any reports of adverse events related to use of the product. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the FDA, it could be dangerous for patients with this serious condition to stop taking their Metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information at
www.fda.gov The Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg lots subject to the recall are identified in the table below.
Check the full recall details on
www.fda.gov
Source: FDA
